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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Moodys
Medtronic
Fish and Richardson
Dow
Farmers Insurance
Healthtrust
Citi
Julphar

Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075417

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NDA 075417 describes CLOZAPINE, which is a drug marketed by Barr Labs Inc, Mylan Pharms Inc, Teva Pharms Usa, Accord Hlthcare, Aurobindo Pharma Ltd, Ivax Sub Teva Pharms, Mayne Pharma, Mylan, Par Pharm, Sandoz, Sun Pharm Inds Inc, and Zydus Pharms Usa Inc, and is included in thirteen NDAs. It is available from eleven suppliers. Additional details are available on the CLOZAPINE profile page.

The generic ingredient in CLOZAPINE is clozapine. There are thirteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the clozapine profile page.
Summary for 075417
Tradename:CLOZAPINE
Applicant:Mylan
Ingredient:clozapine
Patents:0
Therapeutic Class:Antipsychotics
Formulation / Manufacturing:see details
Pharmacology for NDA: 075417
Medical Subject Heading (MeSH) Categories for 075417
Suppliers and Packaging for NDA: 075417
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOZAPINE clozapine TABLET;ORAL 075417 ANDA Mylan Pharmaceuticals Inc. 0378-0825 N 0378-0825-01
CLOZAPINE clozapine TABLET;ORAL 075417 ANDA Mylan Pharmaceuticals Inc. 0378-0860 N 0378-0860-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:May 27, 1999TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:May 27, 1999TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG
Approval Date:Apr 15, 2010TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Daiichi Sankyo
Colorcon
Deloitte
Federal Trade Commission
Julphar
Argus Health
QuintilesIMS
Chinese Patent Office

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